Topical Anaesthesia in Cutaneous Head and Neck Surgery

NCT ID: NCT06274905

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2023-07-07

Brief Summary

This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design.

Detailed Description

Operations on cutaneous tissues of the head and neck are some of the most frequently performed types of operation performed. They can often successfully be performed using local anaesthetic (LA). However, tissues in this anatomic area are some of most sensitive tissues in the body to nociceptive pain. As such, local anaesthetic can be a distressing experience for patients in many ways. Unfortunately, it is also the most common anatomical site for cutaneous malignancies. The majority of these lesions are resected under local anaesthetic. However, one of the major disadvantages of local anaesthetic such as lidocaine is pain during administration.

Several interventions have been used to reduce pain from needles and injections including ethylene chloride cryoanalgesic spray and topical anaesthetic agents including EMLA (lidocaine and prilocaine) and Ametop ointments. These have been extensively used in paediatric populations with great success to reduce pain during procedures requiring hypodermics such as cannulation. Several studies have trialled these interventions in adult populations across a variety of anatomical locations with variable results. The investigators aim to assess the efficacy of EMLA and ethyl chloride in mitigating nociceptive pain associated with local anaesthetic administration in patients undergoing cutaneous head and neck surgery.

Conditions

Pain, Acute; Head and Neck Cancer; Cutaneous Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EMLA cream

EMLA cream 5% 25g lidocaine, 25g prilocaine; Astra Zeneca. Topically applied followed by Tegaderm dressing to cover. Length of duration monitored and recorded as part of study

Group Type: EXPERIMENTAL

EMLA

Intervention Type: DRUG

EMLA cream

EMLA placebo

Aqueous cream ((Ultrapure Laboratories®️, Mayo, Ireland) applied topically followed by covering with Tegaderm dressing. Length of duration monitored and recorded as part of study

Group Type: PLACEBO_COMPARATOR

Aqueous cream BP

Intervention Type: DRUG

Aqueous cream

Ethyl chloride spray

Ethyl chloride spray (Cryogesic®, Fannin Ltd, Dublin, Ireland). Applied topically to surgical site prior to LA injection. Spray at distance of 5-10cm for 4-8 seconds until skin slightly blanched and the fluid allowed to evaporate.

Group Type: EXPERIMENTAL

Ethyl chloride

Intervention Type: DRUG

Ethyl chloride

Control group

No intervention administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EMLA

EMLA cream

Intervention Type: DRUG

Ethyl chloride

Ethyl chloride

Intervention Type: DRUG

Aqueous cream BP

Aqueous cream

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged at least 18 years
• Receiving surgery to cutaneous tissues of the head and neck
• Procedure performed under local anaesthetic

Exclusion Criteria

• Paediatric patients
• Surgery performed under general anaesthetic
• Mucosal operative site (e.g. oral cavity)
• Significant cognitive impairment (e.g. severe dementia)
• Known sensitivity/allergy to EMLA
• History of a pain disorder (e.g. complex regional pain syndrome).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Waterford

OTHER

Sponsor Role: lead

Responsible Party

Rory O'Neill

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Waterford

Waterford, , Ireland

Countries

Ireland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

160123

Identifier Type: -

Identifier Source: org_study_id